1. © HRP Associates, Inc. Informed Consent, Parental Permission & Assent Jeffrey M. Cohen, Ph.D., CIP President, HRP Associates, Inc.

2. © HRP Associates, Inc. Informed Consent Beyond the Consent Form

3. © HRP Associates, Inc. The Consent Process Informed consent is not a single event or just a form to be signed - - rather, it is an educational process that takes place between the investigator and the prospective subject. The basic elements of the consent process include: full disclosure of the nature of the research and the subject's participation, adequate comprehension on the part of the potential subjects, and the subject's voluntary choice to participate.

4. © HRP Associates, Inc. Informed Consent Basic Elements Research – Purpose/Duration – Procedures – Experimental Risks Benefits Alternatives Confidentiality Compensation for Injury Whom to Contact Right to Refuse or Withdraw 46.116(a)

5. © HRP Associates, Inc. Informed Consent Additional Elements Currently Unforeseeable Risks Termination of Participation Additional Costs to Subjects Consequence of Withdrawal Informing of New Findings Number of Subjects 46.116(b) 46.116(b)

6. © HRP Associates, Inc. Comprehension Informed consent is not valid unless the prospective subject understands the information that has been provided. It is the responsibility of the investigator to do what he/she can to enhance each prospective subject's comprehension of the information. The investigator must consider the nature of the proposed subject population, the type of information to be conveyed, and the circumstances under which the consent process will take place in determining the appropriate way to present the information.

7. © HRP Associates, Inc. Comprehension Avoid technical terms Translation Language is appropriate to their age level Different consent procedures may be required with different populations.

8. © HRP Associates, Inc. Voluntary Consent Only legally competent adults can give consent Minors cannot give consent Incompetent adults cannot give consent The evaluation of competence must be made on a case by case basis.

9. © HRP Associates, Inc. Voluntary Consent In order to be valid, consent must be freely given. That means that it is free from all forms of coercion. In addition to overt coercion, the investigator needs to be sensitive to more subtle forms of coercion, such as social pressure, requests from authority figures, and undue incentive for participation.

10. © HRP Associates, Inc. Procedures for Obtaining Consent Subject has the legal and mental capacity to give consent – legally authorized representative; Sufficient opportunity is provided to consider The possibility of coercion or undue influence is minimized Language understandable to the subject No “exculpatory” language 46.116

11. © HRP Associates, Inc. Documentation of Consent “Legally effective informed consent" – written consent form signed by the subject or the subject's legal representative. The consent form is merely the documentation of informed consent The fact that a subject signed a consent form does not mean that he/she understood what was being agreed to or truly gave their voluntary consent. Informed consent is a process which is documented by a signed consent form. 46.117

12. © HRP Associates, Inc. Documentation of Consent It is recommended that consent forms meet four criteria: Be brief, but have complete basic information. Be readable and understandable to most people. Be in a format that helps people comprehend and remember the information. Serve as a script for the face-to-face discussions with the potential subjects.

13. © HRP Associates, Inc. Documentation of Consent Reading Level: Maximum 8th grade reading level (preferably lower) ordinary language active tense shorter sentences logical sequences

14. © HRP Associates, Inc. Documentation of Consent Format can help comprehend and remember complex material. Good format uses: headings; indents; bolded type; lists; extra spacing between sub-topics; repetition; reasonable-size type; and plenty of margins and empty space in general.

15. © HRP Associates, Inc. Documentation of Consent Format can help comprehend and remember complex material. Good format uses: headings; indents; bolded type; lists; extra spacing between sub-topics; repetition; reasonable-size type; and plenty of margins and empty space in general.

16. © HRP Associates, Inc. Minors as Subjects Age of majority is set by the state Unless waived, assent of the children and permission of their parents or guardians is required The requirements for assent of the children and/or permission of their parents or guardians may be waived by the IRB as long as the criteria for waiving consent in the regulations are met

17. © HRP Associates, Inc. Parental Permission Adequate provisions are to be made to secure permission from both parents. – For minimal risk research or risk research with direct benefit, the IRB may allow permission from one parent. – For risk research without direct benefit, permission from both parents is required.

18. © HRP Associates, Inc. Assent “Assent” means a child’s affirmative agreement to participate in research. Mere failure to object should not be construed as assent. [46.402(b)/50.3(n)] Assent from children is required when, in the judgement of the IRB, the children are capable of providing assent. [46.408(a)/50.55(a)] – the IRB shall take into account the ages, maturity, and psychological state of the children involved If the research provides direct benefits to the health or well- being of the child which are only available in the research context, assent may not be required. [46.408(b)/50.55(b)(2)]

19. © HRP Associates, Inc. Documentation Documentation of parental permission shall be in accord with 46.117or 50.27. [46.408(d)/50.55(f)] The IRB shall determine whether and how assent must be documented. [46.408(e)/50.55(g)]

20. © HRP Associates, Inc. IRB Flexibility IRBs have the authority to waive some or all of the requirements for consent and/or documentation of consent provided the research meets the criteria in the regulations.

21. © HRP Associates, Inc. Waiver of Documentation Investigators rarely object to obtaining informed consent from their subjects Investigators do object to obtaining signed consent forms where it is not appropriate. Written informed consent is not necessarily appropriate for all research, especially research in the social & behavioral sciences.

22. © HRP Associates, Inc. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds: – the research presents no more than minimal risk; and – the research involves procedures that do not require written consent when performed outside of a research setting. 45 CFR 46.117(c)(2) Waiver of Documentation

23. © HRP Associates, Inc. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds: – the principle risks are those associated with a breach of confidentiality concerning the subject’s participation in the research; and – the consent document is the only record linking the subject with the research 45 CFR 46.117(c)(1) Waiver of Documentation

24. © HRP Associates, Inc. An IRB may approve a waiver or alteration of some or all of the consent requirements provided that: – The research involves no more than minimal risk to subjects; – The waiver will not adversely affect the rights and welfare of subjects; – The research could not practicably be carried out without the waiver; and – Whenever, appropriate, the subjects will be provided with additional pertinent information after they have participated in the study. 45 CFR 46.116(d) Waiver of Consent

25. © HRP Associates, Inc. Points to Remember Whenever consent or documentation is waived, IRB must find and document that the research meets the criteria Deception research requires a waiver of consent with appropriate documentation "Passive consent" or "implied consent" is not consent and requires a waiver with appropriate documentation IRBs should not be afraid to exercise their waiver authority if the research meets the criteria and the finding is appropriately documented.

26. © HRP Associates, Inc. Summary Informed consent is a process, not a piece of paper Regulations specify how consent is to be obtained and what information is provided. Consent is generally documented through a signed, written consent form For minors, parental permission and assent are generally required IRBs have the authority to waive some or all of the requirements for consent and/or documentation of consent